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Study of A3309 in Patients With Dyslipidemia

This study has been completed.
Information provided by (Responsible Party):
Albireo Identifier:
First received: February 16, 2010
Last updated: October 12, 2016
Last verified: October 2016
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol levels).

Condition Intervention Phase
Drug: A3309
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia

Resource links provided by NLM:

Further study details as provided by Albireo:

Primary Outcome Measures:
  • Change from baseline in low-density lipoprotein (LDL) cholesterol [ Time Frame: eight weeks ]

Enrollment: 36
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A3309 low dose Drug: A3309
A3309 in two different dosage levels
Drug: A3309
A3309 in two different dosage levels for the duration of the study
Experimental: A3309 high dose Drug: A3309
A3309 in two different dosage levels
Drug: A3309
A3309 in two different dosage levels for the duration of the study
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator once daily for the duration of the trial


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings

Exclusion Criteria:

  • Medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT01069783

Linköping, Sweden
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Albireo Identifier: NCT01069783     History of Changes
Other Study ID Numbers: A3309-005
Study First Received: February 16, 2010
Last Updated: October 12, 2016

Keywords provided by Albireo:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on April 26, 2017